A prominent cardiologist told a government official that Merck & Co. had engaged in “scientific misconduct” in its handling of its Vioxx painkiller, according to evidence presented in a federal trial.
Eric Topol, provost of the Cleveland Clinic College of Medicine, said in videotaped testimony in the first federal Vioxx trial Saturday that Merck had data years before its September 2004 withdrawal of the painkiller that suggested Vioxx posed cardiovascular dangers.
Last year, Merck voluntarily withdrew Vioxx from the market after a study linked the drug to increased risk of heart attacks and strokes in patients who took the drug for 18 months or longer. Merck was hit with thousands of lawsuits; it has won one case and lost another.
In the federal court case, Evelyn Irvin Plunkett is suing Merck over the 2001 fatal heart attack of her husband Richard “Dicky” Irvin, who took Vioxx for less than a month before he died.
Judge Eldon E. Fallon of New Orleans who is hearing the case in Houston because of Hurricane Katrina, is pressing lawyers on both sides to finish in two weeks. Plaintiff’s lawyers could rest as early as today. Ms. Plunkett is expected to take the stand. Dr. Topol wasn’t a witness in the first two trials and was subpoenaed for this case by plaintiff’s lawyers.
One of the first scientists to raise questions about Vioxx’s safety, Dr. Topol encountered controversy late last year when it was revealed he was a paid adviser to a hedge fund that had profited by betting Merck shares would fall. Dr. Topol resigned from the fund, Great Point Partners LLC of Greenwich, Conn., and says he never discussed Vioxx with the fund, wasn’t an investor in the fund and has never profited from his views on Vioxx. Merck lawyers didn’t question Dr. Topol about his dealings with the fund during his testimony, and the matter wasn’t presented to the jury.
Under questioning, Dr. Topol described how he concluded Vioxx increases heart-attack risks in a study he published in August 2001 in the Journal of the American Medical Association. Prior to publishing, Dr. Topol sent Merck a draft of his paper. He testified Merck scientists visited him in Cleveland to tell him he “got it wrong” and would be “embarrassed” if his paper were to appear.
Dr. Topol challenged Merck’s explanation for the results of a 2000 study that compared Vioxx with naproxen, an older painkiller, in which patients on Vioxx had four to five times as many heart attacks. Merck had concluded naproxen worked to protect the heart, but Dr. Topol said “the only appropriate conclusion” was that Vioxx had a problem.
Following the withdrawal of Vioxx, Dr. Topol sent an email to David Graham, a Food and Drug Administration official, that said he was “bothered” by Merck’s “scientific misconduct,” which he felt didn’t receive adequate attention.
Under cross-examination by a Merck defense lawyer, Dr. Topol said he had taken Vioxx occasionally starting in 1999 for arthritis in his knees. It gave him more relief than older painkillers, and he didn’t feel his personal health profile put him at risk, he said.
Jurors were shown videotaped testimony from Christopher Schirmer, Mr. Irvin’s son-in-law, an emergency-room physician who prescribed Vioxx to Mr. Irvin. Dr. Schirmer said he wasn’t Mr. Irvin’s regular doctor, and had “no knowledge” of following up with any doctors who treated Mr. Irvin. He testified he had no notes regarding Mr. Irvin’s health. When questioned about whether he considered his father-in-law to be at heightened risk for cardiovascular events, Dr. Schirmer said, “I never really gave it too much thought at that time.”